960-Patient Study Demonstrates Zero Blood Stream Infection In Patients Treated With Angiotech's Novel 5-FU Central Venous Catheter



    Study Successfully Hit Primary End Point of Preventing Bacterial
    Colonization with a Trend Toward Superiority over the Market Leader

    VANCOUVER, March 18 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ:  
ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company,
announced today that the clinical data from its 960 patient clinical trial
comparing its 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC) with
a chlorhexidine/silver sulfadiazine (CH-SS) coated CVC was presented by the
clinical investigators at the 28th International Symposium on Intensive Care
and Emergency Medicine (ISICEM) in Brussels, Belgium. Angiotech believes this
study is the largest head-to-head coated CVC clinical trial ever completed.
    Based on the clinical trial data, the investigators concluded that
Angiotech's 5-FU CVC met the primary endpoint of the study: non-inferior in
its ability to prevent bacterial colonization of the catheter tip when
compared to catheters coated with CH-SS. The rate of colonization of the 5-FU
CVC was 2.9% (n=12), compared to 5.3% (n=21) in the CH-SS coated catheters
(relative reduction in colonization with 5-FU coating of 46%, p=0.055).
    There were no statistically significant differences in the rate of
adverse events related to the study devices (2.5% for 5-FU vs. 3.1% for
CH-SS), or in the rates of catheter-related bloodstream infections (CRBSI),
(0% for 5-FU vs. 2.8% for CH-SS). Additionally, there was no evidence for
acquired resistance to 5-FU in clinical isolates exposed to the drug for a
second time.

    
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    Outcome                            5-FU CVC  CH-SS CVC  Endpoint met?
    -------------------------------------------------------------------------
    Catheter colonization                 2.9%      5.3%       Yes
    -------------------------------------------------------------------------
    Catheter-related blood stream
     infections                             0%      2.8%      p= 0.2
    -------------------------------------------------------------------------
    Adverse Events, related to study
     device                               2.5%      3.1%       N/A
    -----------------------------------------------------
    Microbiology
    -----------------------------------------------------
      Coagulase-negative staphylococcus     4         8
    -----------------------------------------------------
      Methicillin-resistant
       staphylococcus aureus                0         3
    -----------------------------------------------------
      Gram-negative bacteria                0       6(*)
    -----------------------------------------------------
      Fungal species                        0       2(*)
    -------------------------------------------------------------------------
    (*) Including catheter-related blood stream infection
    

    As important as the zero rate of catheter-related blood stream infection,
the low rate of colonization and the types of organisms implicated are also
important. The Angiotech 5-FU coated CVCs were infrequently colonized, and
only with S. epidermis and common skin contaminants. In addition to S.
epidermis and common skin contaminants, the catheters with CH-SS were also
colonized with methicillin-resistant S. aureus, E. coli, K. pneumoniae, P.
mirabilis, S. marcescens, and A. baumannii. Both of the blood stream
infections in this study were associated with the CH-SS catheter which grew
Candida and gram-negative bacteria, pathogens associated with poor patient
outcomes. The spectrum of organisms involved will give clinicians reason to
choose Angiotech's 5-FU coated catheter over existing devices.
    In addition to meeting the non-inferiority endpoint, these data show a
trend toward superiority for the 5-FU coated catheter over the market leading
device, both in frequency and nature of colonizations and infections. This
efficacy comes without the public health risk that accompanies the long-term,
low level exposure to important anti-microbials such as chlorhexidine and
silver sulfadiazine or antibiotics like rifampin. Angiotech's ground breaking
5-FU technology achieves improved anti-infective performance without the risk
of clinically meaningful bacterial or fungal resistance, a unique property
among anti-infective coatings.
    "We are extremely pleased with the clinical results of the 5-FU CVC
trial. Achieving zero percent blood stream infection bodes well for a most
vulnerable patient population and has very positive implications for the
expansion of our 5-FU anti-infective platform. To observe substantial
anti-infective performance without exposure to antiseptics or antibiotics is
very important to all clinicians, especially infectious disease and infection
control experts," said Dr. William Hunter, President and CEO of Angiotech.
    Angiotech submitted a 510(k) application to the U.S. Food and Drug
Administration (FDA) for its 5-FU CVC in December 2007 and is finalising
commercialization plans for the product.

    About the Study

    This study was a multi-center (25 U.S. sites), randomized clinical trial
conducted to compare the efficacy of our novel 5-FU-eluting CVC to a CH-SS
coated CVC in preventing catheter colonization, local site infection and
CRBSI.

    About CVC and Catheter-Related Infections

    Central venous catheters are usually inserted into critically ill
patients for extended periods of time to administer fluids, drugs, and
nutrition, as well as facilitate frequent blood draws. One of the
complications associated with CVC implantation is infection, which can occur
when micro-organisms contaminate the catheter. Catheter related bloodstream
infections are estimated to occur at an annual rate of 80,000 to 250,000 cases
in the US, resulting in increased mortality, cost, and length of stay.(1-4)
The attributable mortality of CRBSI is estimated at 11%.(5) In the U.S., the
cost per catheter-related infection can range from $3,700 to $29,000.(6) In
addition, the Centers for Disease Control and Prevention (CDC) has raised
concerns about the overuse of traditional antibiotics and antiseptics, which
can contribute to an increase in bacterial resistance.

    About Angiotech's 5-FU CVC

    Angiotech has demonstrated that 5-FU, a well-known and approved compound,
has utility to prevent catheter-related infections as effectively as
traditional antiseptics and antibiotics. In addition, since 5-FU has no
clinical application as either a systemic antibiotic or a hospital antiseptic,
there is a reduced risk to the hospital or the community at-large of creating
a "super-bug" that may be resistant to useful classes of antibiotics and
antispectics and may make infection control more complex. The alarming
increase in microbial resistance is one of the CDC's top concerns.
    The principle behind using 5-FU on a CVC is that the drug acts through
multiple pathways to inhibit bacterial growth and metabolic functions of most
microorganisms. Adding a very minute amount of 5-FU to the surface of a device
makes that surface a very hostile environment for a microorganism, with
unchanged tolerability for the patient. Our 5-FU technology can also
effectively impair biofilm formation that may lead to colonization and
infection. This reduction in colonization by bacteria may have a net effect of
reducing biofilm burden on the implanted devices, making them less likely to
serve as reservoirs for additional infection.

    Note on Forward Looking Statements

    Statements contained in this press release that are not based on
historical fact, including without limitation statements containing the words
"believes," "may," "plans," "will," "estimate," "continue," "anticipates,"
"intends," "expects" and similar expressions, constitute "forward-looking
statements" within the meaning of the U.S. Private Securities Litigation
Reform Act of 1995 and constitute "forward-looking information" within the
meaning of applicable Canadian securities laws. All such statements are made
pursuant to the "safe harbor" provisions of applicable securities legislation.
Forward-looking statements may involve, but are not limited to, comments with
respect to our strategies or future actions, our targets, expectations for our
financial condition and the results of, or outlook for, our operations,
research development and product and drug development. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
that may cause the actual results, events or developments to be materially
different from any future results, events or developments expressed or implied
by such forward-looking statements. Many such risks, uncertainties and other
factors are taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the following: general
economic and business conditions, both nationally and in the regions in which
we operate; market demand; technological changes that could impact our
existing products or our ability to develop and commercialize future products;
competition; existing governmental regulations and changes in, or the failure
to comply with, governmental regulations; adverse results or unexpected delays
in drug discovery and clinical development processes; decisions, and the
timing of decisions, made by health regulatory agencies regarding approval of
our technology and products; the requirement for substantial funding to
conduct research and development and to expand commercialization activities or
consummate acquisitions; the accuracy of our estimations of the size of the
market, and the potential market, for our products in specific disease areas;
sales numbers and future guidance publicly provided by Boston Scientific
Corporation regarding sales of their paclitaxel-eluting coronary stent
products; and any other factors that may affect performance. In addition, our
business is subject to certain operating risks that may cause the actual
results expressed or implied by the forward-looking statements in this report
to differ materially from our actual results. These operating risks include:
our ability to attract and retain qualified personnel; our ability to
successfully complete preclinical and clinical development of our products;
changes in business strategy or development plans; our failure to obtain
patent protection for discoveries; loss of patent protection resulting from
third party challenges to our patents; commercialization limitations imposed
by patents owned or controlled by third parties; our ability to obtain rights
to technology from licensors; liability for patent claims and other claims
asserted against us; our ability to obtain and enforce timely patent and other
intellectual property protection for our technology and products; the ability
to enter into, and to maintain, corporate alliances relating to the
development and commercialization of our technology and products; market
acceptance of our technology and products; our ability to successfully
manufacture, market and sell our products; the ability of Boston Scientific
Corporation to successfully manufacture, market and sell their
paclitaxel-eluting coronary stent products; the continued availability of
capital to finance our activities; our ability to achieve the financial
benefits expected as a result of the acquisition of American Medical
Instruments Holdings, Inc. ("AMI"); and any other factors referenced in our
annual information form and other filings with the applicable Canadian
securities regulatory authorities or the SEC. Given these uncertainties,
assumptions and risk factors, readers are cautioned not to place undue
reliance on such forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce the result of any revisions to
any of the forward-looking statements contained in this press release to
reflect future results, events or developments.

    About Angiotech

    Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and
medical device company with over 1,500 dedicated employees. Angiotech
discovers, develops and markets innovative treatment solutions for diseases or
complications associated with medical device implants, surgical interventions
and acute injury. To find out more about Angiotech (NASDAQ:   ANPI, TSX: ANP),
please visit our website at www.angiotech.com.

    
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    (1) Maki, DG et al. Mayo Clin Proc 2006;81:1159-1171.
    (2) Orsi, GB et al. Infect Control Hosp Epidemiol 2002;23:190-197.
    (3) Blot, SI et al. Clin Infect Dis 2005;41:1591-1598.
    (4) O'Grady, NP et al. MMWR Recomm Rep 2002;51:1-29.
    (5) Renaud, B et al. Am J Respir Crit Care Med 2001;163:1584-1590
    (6) Mermel, LA. Prevention of intravascular catheter-related infections.
        Ann Intern Med. 2000; 132:391-402.
    





For further information:

For further information: Deirdre Neary, Angiotech Pharmaceuticals, Inc.,
(604) 222-7056, dneary@angio.com

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